Coronary access after ACURATE neo2 implantation for valve-in-valve TAVR: Insights from ex vivo simulations.
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SUBMITTER: Khokhar AA
PROVIDER: S-EPMC9826017 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
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Coronary access after ACURATE neo2 implantation for valve-in-valve TAVR: Insights from ex vivo simulations.
Khokhar Arif A AA Giannini Francesco F Zlahoda-Huzior Adriana A Mikhail Ghada G Dudek Dariusz D
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20220918 4
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| S-EPMC9725048 | biostudies-literature
Project description:BackgroundNo comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV).AimsWe aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV.MethodsA total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs. Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups.ConclusionsShort-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.
| S-EPMC9853033 | biostudies-literature
Project description:BackgroundCoronary access after transcatheter aortic valve implantation (TAVI) with supra-annular self-expandable valves may be challenging or un-feasible. There is little data concerning coronary access following transcatheter aortic valve-in-valve implantation (ViV-TAVI) for degenerated surgical bioprosthesis.AimsTo evaluate the feasibility and challenge of coronary access after ViV-TAVI with the supra-annular self-expandable ACURATE neo valve.Materials and methodsSixteen patients underwent ViV-TAVI with the ACURATE neo valve. Post-procedural computed tomography (CT) was used to create 3D-printed life-sized patient-specific models for bench-testing of coronary cannulation. Primary endpoint was feasibility of diagnostic angiography and PCI. Secondary endpoints included incidence of challenging cannulation for both diagnostic catheters (DC) and guiding catheters (GC). The association between challenging cannulations with aortic and transcatheter/surgical valve geometry was evaluated using pre and post-procedural CT scans.ResultsDiagnostic angiography and PCI were feasible for 97 and 95% of models respectively. All non-feasible procedures occurred in ostia that underwent prophylactic "chimney" stenting. DC cannulation was challenging in 17% of models and was associated with a narrower SoV width (30 vs. 35 mm, p < 0.01), STJ width (28 vs. 32 mm, p < 0.05) and shorter STJ height (15 vs. 17 mm, p < 0.05). GC cannulation was challenging in 23% of models and was associated with narrower STJ width (28 vs. 32 mm, p < 0.05), smaller transcatheter-to-coronary distance (5 vs. 9.2 mm, p < 0.05) and a worse coronary-commissural overlap angle (14.3° vs. 25.6 o , p < 0.01). Advanced techniques to achieve GC cannulation were required in 22/64 (34%) of cases.ConclusionIn this exploratory bench analysis, diagnostic angiography and PCI was feasible in almost all cases following ViV-TAVI with the ACURATE neo valve. Prophylactic coronary stenting, higher implantation, narrower aortic sinus dimensions and commissural misalignment were associated with an increased challenge of coronary cannulation.
| S-EPMC9515364 | biostudies-literature
Project description:Background ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. Methods and Results The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory-adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. Conclusions In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.
| S-EPMC10493001 | biostudies-literature
Project description:BackgroundTranscatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve.MethodsThe primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months.ResultsThe study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL.ConclusionsOne-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve.
| S-EPMC8639565 | biostudies-literature
Project description:BackgroundTranscatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation.AimsWe sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting.MethodsValve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography).ResultsThe study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL).ConclusionsThe study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).
| S-EPMC10756225 | biostudies-literature
Project description:Background Transcatheter aortic valve replacement (TAVR)-in-TAVR is a possible treatment for transcatheter heart valve (THV) degeneration. However, the displaced leaflets of the first THV will create a risk plane (RP) under which the passage of a coronary catheter will be impossible. The aim of our study was to evaluate the potential risk of impaired coronary access (CA) after TAVR-in-TAVR. Methods and Results We prospectively performed coronary angiography after TAVR with different THVs in 137 consecutive patients, looking where the catheter crossed the valve frame. If coronary cannulation was achieved from below the RP, the distance between valve frame and aortic wall was measured by aortic angiography. CA after TAVR-in-TAVR was defined as feasible if the catheter passed above the RP, as theoretically feasible if passed under the RP with valve-to-aorta distance >2 mm, and as unfeasible if passed under the RP with valve-to-aorta distance ≤2 mm. Seventy-two patients (53%) received a Sapien 3 THV, 26 (19%) received an Evolut Pro/R THV, and 39 (28%) received an Acurate Neo THV. CA after TAVR-in-TAVR was considered feasible in 40.9% (68.1%, 19.2%, and 5.1%, respectively; P<0.001), theoretically feasible in 27.7% (8.3%, 42.3%, and 53.8%, respectively; P<0.001), and unfeasible in 31.4% (23.6%, 38.5%, and 41.1%, respectively; P=0.116). Independent predictors of impaired CA after TAVR-in-TAVR were female sex (odds ratio [OR], 3.99; 95% CI, 1.07-14.86; P=0.040), sinotubular junction diameter (OR, 0.62; 95% CI, 0.48-0.80; P<0.001), and implantation of a supra-annular THV (OR, 6.61; 95% CI, 1.98-22.03; P=0.002). Conclusions CA after TAVR-in-TAVR might be unfeasible in >30% of patients currently treated with TAVR. Patients with a small sinotubular junction and those who received a supra-annular THV are at highest risk of potential CA impairment with TAVR-in-TAVR.
| S-EPMC7670517 | biostudies-literature
Project description:Based on the strength of data from randomized trials and real-world clinical studies, transcatheter aortic valve replacement (TAVR) has become a popular and effective alternative to surgical valve replacement in patients with symptomatic aortic stenosis. The ACURATE neo™ (Boston Scientific, Marlborough, MA, USA) valve system has been commercially available for transfemoral TAVR in Europe since 2014. ACURATE neo2™ is an evolution of the neo design and was declared CE marked by the manufacturer in 2020. The neo and neo2 valves have been studied in high-risk patients, and the currently active randomized trial for neo2 will include over 1,500 patients of all risk categories in the USA. The goal of this review is to help inform the TAVR community about the ACURATE valve.
| S-EPMC9524845 | biostudies-literature
Project description:BackgroundSutureless bioprosthetic valves (SBVs) are engineered to enable a less invasive surgical valve replacement procedure in patients at high surgical risk. Valve degeneration is a relatively common occurrence across all types of surgical valves, including SBVs. Valve-in-valve (ViV) procedures are increasingly becoming the preferred treatment for many cases of valve degeneration due to their minimally invasive nature and favourable long-term outcomes. However, the specific structural characteristics of SBVs present challenges for ViV procedures, and the evidence on this subject remains limited.Case summaryA 91-year-old man was admitted to our hospital presenting with dyspnoea due to severe aortic regurgitation in a degenerated 3F Enable sutureless valve. Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) was successfully performed using a self-expanding Acurate Neo2 valve, yielding good haemodynamic results without overt interaction between the prosthesis. A 6-month follow-up echocardiogram confirmed excellent valve performance.DiscussionViV-TAVI is a well-established treatment for bioprosthetic valve failure in high-risk patients. However, sutureless valve degeneration presents a challenging scenario for ViV procedures, with only a limited number of cases performed using the Acurate platform. In this case, we demonstrated the technical feasibility of ViV using the Acurate system in a less explored surgical sutureless bioprosthesis.
| S-EPMC11895507 | biostudies-literature
Project description:BackgroundThe ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR).AimsWe sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices.MethodsThe NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification.ResultsA total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001).ConclusionsThis retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.
| S-EPMC9853030 | biostudies-literature